Off-script Diagnosis & Differential Diagnosis (D&D) Training and Residents' Stroke Knowledge (CAST-AIS)

Effectiveness of Off-script Diagnosis & Differential Diagnosis (D&D) Training in Improving Residents' Competence in Acute Ischemic Stroke Diagnosis and Treatment

This study is a single-center, randomized, open-label, controlled, endpoint-blinded study to assess the effect of off-script diagnosis & differential diagnosis (D&D) training in improving the residents' knowledge of acute ischemic stroke in China. The investigators will enroll 22 residents and assess the score of mASMaQ 30 days after randomization.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Acute; Educational Problems; Clinical Course
• Intervention / Treatment: Other: Off-script diagnosis & differential diagnosis (D&D) training

Detailed Description

Ischemic stroke is characterized by high incidence and disability rates, with a critical time window for reperfusion therapy, necessitating prompt recognition, diagnosis, and treatment by frontline physicians. In clinical practice, residents across all specialties may encounter acute ischemic stroke (AIS) patients in emergency departments, outpatient clinics, or inpatient wards. However, many residents face challenges in managing AIS cases, often leading to missed diagnoses, treatment delays, and non-adherence to clinical guidelines. A primary contributing factor is their insufficient mastery of key AIS management principles and inability to effectively apply stroke knowledge in clinical contexts.

Enhancing residents' AIS management competence represents a significant challenge in stroke education. Traditional "Initial Progress Note" training overemphasizes comprehensive differential diagnoses, with most residents relying on scripted presentations. The actual clinical application of stroke knowledge remains uncertain. This study aims to evaluate whether off-script diagnosis & differential diagnosis (D&D) training (i.e., "Structured off-script D&D") can significantly improve residents' AIS management knowledge.

The investigators will enroll 22 neurology residents and randomly assign them to two groups: the off-script diagnosis & differential diagnosis (D&D) training group (n=11) and a blank control group (n=11). The modified Acute Stroke Management Questionnaire (mASMaQ) will be used to assess residents' AIS knowledge 30 days after randomization.

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shengde Li, MD; Phone Number: 17896002828; Email: lishengde.medicine@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Shengde Li, MD; Phone Number: 17896002828; Email: lishengde.medicine@qq.com
      • Principal Investigator: Jun Ni

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Residents (physicians in postgraduate training).
2. Currently in neurology wards
3. Managing acute ischemic stroke (AIS) patients, defined as: 1)Time from onset to randomization ≤ 2 weeks; 2) If onset time is unknown, the last known well time is considered the onset time.
4. Signed informed consent

Exclusion Criteria:

1. Managing asymptomatic ischemic stroke patients.
2. Residents who are currently participating or have participated in another interventional ischemic stroke training program within the past 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Off-script D&D training group; Off-script D&D training is required within 72 hours after randomization.	Other: Off-script diagnosis & differential diagnosis (D&D) training; Training Timeline: Must be completed within 72 hours post-randomization; Requires standardized structured off-script D&D analysis.; Structured Analysis Framework: 1)Epidemiology: Incidence, mortality, and disability rates; 2) Etiologic Classification: TOAST classification system; 3) Vascular Mechanisms: Culprit vessel, vascular territory, pathophysiology; 4) Differential Diagnosis: Stroke mimics and stroke subtype differentiation; 5) Acute Management: Hyperacute interventions (thrombolysis/EVT), secondary prevention strategies, and evidence-based case analysis; 6) Patient Education: Stroke prevention education for patients/public; 7) Research Gaps: Current limitations and future directions.; Presentation Requirements: 1)Mandatory off-script delivery (no prepared text); 2) Time limit: 15+3 minutes for complete analysis.
No Intervention: No-Intervention Control Group; Off-script D&D training is not required within 72 hours after randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mASMaQ	Modified Acute Stroke Management Questionnaire (mASMaQ), with a range of 33-165 scores. Higher scores indicate superior acute ischemic stroke management knowledge. Blinded Assessment Protocol:1) Participant Requirements: Strict 10-minute time limit for independent completion; External references are prohibited; 2) Assessment Supervision: certified neurologists as proctors, who are blinded to group assignment throughout the trial. 3) Centralized Adjudication: based on participants' questionnaire responses. Note: Details of the modified ASMaQ has been on file with the ethics committee and cannot be changed. To prevent disclosure of the measures and bias in resident measurement, we do not disclose the scales until the trial is completed. Details of mASMaQ will be made public with the publication of the article.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General stroke knowledge	Part of mASMaQ, with a range of 10-50. Higher scores indicate superior general stroke knowledge.	30 days
Hyperacute stroke management	Part of mASMaQ, with a range of 9-45. Higher scores indicate superior hyperacute stroke management knowledge.	30 days
Advanced stroke management	Part of mASMaQ, with a range of 14-70. Higher scores indicate superior advanced stroke management knowledge.	30 days

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Jun Ni, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: resident; stroke education
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Disease Attributes; Stroke; Disease Progression
• Other Study ID Numbers: CAST-AIS2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No